Application 208715
- Type
- NDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CABAZITAXEL | CABAZITAXEL | SOLUTION;INTRAVENOUS | 45MG/4.5ML (10MG/ML) | Yes | Yes |
| 002 | CABAZITAXEL INJECTION | CABAZITAXEL | INJECTABLE;INJECTION | 60MG/6ML | No | No |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208715-001 | CABAZITAXEL | 45MG/4.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208715-002 | CABAZITAXEL | 60MG/6ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208715-001 | CABAZITAXEL | 45MG/4.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208715-002 | CABAZITAXEL | 60MG/6ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208715-001 | CABAZITAXEL | 45MG/4.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208715-002 | CABAZITAXEL | 60MG/6ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208715-001 | CABAZITAXEL | 45MG/4.5ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208715-002 | CABAZITAXEL | 60MG/6ML (10MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-01-05 | 053a50430f4f… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Jevtana | CABAZITAXEL | Sanofi-Aventis U.S. LLC | de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | CABAZITAXEL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.